NCT03849976

Brief Summary

Anxiety is a form of psychic and/or physical discomfort caused by the feeling of the imminence of a danger. It is a frequent perioperative manifestation of patients. Pharmacological premedication is currently used to avoid perioperative anxiety. However, its effect is now controversial and non-drug techniques have been also studied. The therapeutic communication aims to provide analgesia or anxiolysis to enhance the patient's well-being and to separate the patient from the surrounding reality through the suggestion of positive images with a chosen verbal and nonverbal approach. This prospective, monocentric, comparative, double-blind study aims to evaluate the impact of the training of stretcher-bearers in therapeutic communication on the anxiety of patients who go to the operating room for an endoscopic examination under general anaesthesia.Two groups of patients will be compared: In the first group patients will be accompanied to the operating room by a stretcher-bearer trained in therapeutic communication, in the second group patients will be accompanied by a stretcher bearer without this specific training.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2019

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

February 13, 2019

Last Update Submit

February 2, 2021

Conditions

Anxiety

Keywords

Therapeutic communicationAnxietyEndoscopic examination under general anesthesiaOperating roomStretcher bearer

Outcome Measures

Primary Outcomes (2)

  • Anxiety scale: State-Trait Anxiety Inventory (STAI-Y), form A

    This scale is composed of 20 propositions to know how the subject feels. Each item has a score from 1 to 4 (4 being the highest degree of anxiety). The score therefore varies from 20 to 80.

    Day one (before intervention)

  • Amsterdam Preoperative Anxiety and Information Scale (APAIS)

    The APAIS questionnaire includes 6 questions, 2 of which evaluate the patient's anxiety about anesthesia, 2 questions estimate the anxiety about the procedure, the last 2 questions evaluate the patient's need for information about anesthesia and the procedure. Each question is rated from 1 to 5, the scale allows to calculate 4 scores (anesthetic anxiety/intervention anxiety/global and information request score). Subjects are considered anxious when they have a score higher than 11 for these 4 items.

    Day one (before intervention)

Secondary Outcomes (2)

  • Evaluation of the experience of general anesthesia (EVAN-G) scale

    In average one day (at hospital discharge)

  • Likert scale

    Day one (at the end of the intervention)

Study Arms (2)

Experimental group

Patients accompanied to the operating room by a stretcher bearer trained in therapeutic communication

Behavioral: Therapeutic communication

Control group

Patients accompanied to the operating room by a stretcher bearer not trained in therapeutic communication

Interventions

Therapeutic communicationBEHAVIORAL

Patients will be accompanied to the operating room by a stretcher bearer trained in therapeutic communication

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients in ambulatory sector for endoscopic examination under general anesthesia.

You may qualify if:

  • Major patients
  • Hospitalized in the ambulatory sector for endoscopic examination under general anesthesia (fibroscopy/colonoscopy/others)
  • Able to answer anxiety questionnaires
  • Able to walk to the operating room according to the usual practice (no motor disorder)
  • Not presenting a psychiatric or cognitive disorder, or a non-paired hearing disorder that may interfere with therapeutic communication
  • Being informed and not being opposed

You may not qualify if:

  • Refusal to participate in the study
  • Patients under guardianship
  • Patient who received premedication before going down to the operating room (benzodiazepines, gabapentin, antihistamines)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lille Catholic Hospitals

Lomme, Nord, 59462, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Christophe Canevet

    Lille Catholic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2019

First Posted

February 21, 2019

Study Start

October 25, 2018

Primary Completion

December 17, 2019

Study Completion

December 17, 2019

Last Updated

February 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)